MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-12 for PHILIPS PAGEWRITER TC-70 CARDIOGRAPH MACHINES PAGE WRITER TC-70 manufactured by Philips.
[94850459]
Time stamps recorded on the philips 12 lead ecg carts can be inaccurate by one hour. The time associated with 12 lead ecgs seems to be affected by the daylights savings and a synchronization errors with a main server. Philips continues to deny previous knowledge of this issue and will not provide documentation to warn our clinicians about the time associated with a 12 lead recording fluctuating between standard time and daylight savings time. While at the same time philips states that they have a software patch that has been in the works for over a month, designed to address the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073928 |
| MDR Report Key | 7112058 |
| Date Received | 2017-12-12 |
| Date of Report | 2017-12-11 |
| Date of Event | 2017-12-11 |
| Date Added to Maude | 2017-12-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PHILIPS PAGEWRITER TC-70 CARDIOGRAPH MACHINES |
| Generic Name | ECG MACHINES |
| Product Code | DPS |
| Date Received | 2017-12-12 |
| Model Number | PAGE WRITER TC-70 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-12 |